H2 blocker free chemotherapy

The safety of omission of H2 antagonist from pre medication strategy in patients planned to receive conventional paclitaxel infusion: An investigator initiated randomized double blind placebo controlled non inferiority trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/038139

Enrollment

284

Registered

2021-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Intervention Arm: Dexamethasone (8mg - weekly, 12mg - 3 weekly) + Pheniramine 45.5mg (Inj. Avil 2ml ivp) + Normal saline (NS) as Placebo Control Intervention1: Control Arm: Dexamethas

Eligibility

Inclusion criteria

Inclusion criteria: Adults patients with age between 18 years to 70 years Histopathological diagnosis of cancer Willing to participate and to give written informed consent Planned to receive conventional paclitaxel chemotherapy either as single agent or in combination Paclitaxel naive No known hypersensitivity to partner chemotherapy drug ECOG performance status 0-2 Stable baseline vital signs: Afebrile, radial artery blood pressure (90/60 â?? 130/90mm Hg), pulse rate 60 â?? 100 / minutes, respiratory rate 12-18/ minutes, 97.8 Â°F to 99.1 Â°F (36.5Â° C to 37.3Â° C)

Exclusion criteria

Exclusion criteria: Past history of hypersensitivity reaction to paclitaxel or cremophor containing drugs (cyclosporine, propofol, diazepam, teniposide, etoposide, Vitamin K) or partner drug or pheniramine or ranitidine On chronic systemic steroids or received any dose in the last week No history of hypersensitivity to partner drug Hb 2mg/dl, Bilirubin > 5 X ULN, transaminases 10 times or more

Design outcomes

Primary

Measure	Time frame
To determine the incidence of all grade paclitaxel infusion related acute hypersensitivity reaction without H2 antagonist administrationTimepoint: 4 - 5 hours	—

Secondary

Measure	Time frame
To determine the incidence of severe grade (3 or more) paclitaxel infusion related acute hypersensitivity reaction without H2 antagonist administration To determine the risk factor associated with paclitaxel infusion related acute hypersensitivity reaction To determine the incidence and time to paclitaxel infusion related acute hypersensitivity reaction in the different paclitaxel dose schedule (50 â?? 80mg/m2, 175mg/m2) Timepoint: 4-5 hours	—

Measure

Time frame

To determine the incidence of severe grade (3 or more) paclitaxel infusion related acute hypersensitivity reaction without H2 antagonist administration To determine the risk factor associated with paclitaxel infusion related acute hypersensitivity reaction To determine the incidence and time to paclitaxel infusion related acute hypersensitivity reaction in the different paclitaxel dose schedule (50 â?? 80mg/m2, 175mg/m2) Timepoint: 4-5 hours

—

Countries

India

Contacts

Public ContactAkash Kumar

NCI AIIMS, Badsa

akashjha08@gmail.com9910850134

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026